跳至主要内容
临床试验/NCT06188819
NCT06188819进行中(未招募)不适用

Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection

University Paul Sabatier of Toulouse0 个研究点目标入组 150 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
150
主要终点
Reintervention

研究概览

简要总结

While surgery with anatomic reconstruction of prosthetic aortic infections and native infectious aortitis has become established over time, the ideal substitute is not clearly defined. The cryopreserved arterial allograft (AAC) recognized as resistant to infections not only presents availability problems making its use complicated, particularly in emergencies, with a certain number of long-term aneurysmal developments. The tubulized pericardium patch (PP), available in all cases, seems to give promising results in recent literature. The investigators propose a comparative study of these two substitutes in this indication.

We carried out a two-center observational study including retrospectively from January 2010 to July 2023 all patients operated on for aortic prosthesis infection and native infectious aortitis with AAC reconstruction and prospectively PP patch reconstructions from July 2018 to July 2023. The diagnosis of infection was established according to the MAGIC criteria. The patients' preoperative comorbidities were collected to compare the groups. Postoperative morbidity and mortality was then compared. The medium-term evaluation consisted of comparing according to the Kaplan Meier method: postoperative mortality, permeability, reinfection rate, reoperation rate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All aortic intervention performed for native aortic infection reconstruction with patch or allograft
  • All aortic intervention performed for infected graft reconstruction with patch or allograft

排除标准

  • 未提供

结局指标

主要结局

Reintervention

时间窗: 30 days, 6 months, 12 months, 24 months

Rate of reintervention during post operative stay

Post operative Major cardiovascular adverse events (MACE)

时间窗: day 30 post operative

Rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

Mortality

时间窗: day 30 post operative

Number of patients death during post operative stay

次要结局

  • Reinfection(30 days, 6 months, 12 months, 24 months)
  • Permeability(30 days, 6 months, 12 months, 24 months)

研究者

发起方
University Paul Sabatier of Toulouse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aurélien Hostalrich

Clinical Professor

University Paul Sabatier of Toulouse

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